The acellular pertussis vaccine components are produced
from Bordetellapertussis cultures grown in Stainer-Scholte medium (2) modified
by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and
PRN are isolated separately from the supernatant culture medium. The FIM
components are extracted and co-purified from the bacterial cells. The pertussis
antigens are purified by sequential filtration, salt-precipitation,
ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA
is treated with formaldehyde, and the residual aldehydes are removed by
ultrafiltration. The individual antigens are adsorbed separately onto aluminum
phosphate.

The adsorbed diphtheria, tetanus and acellular pertussis
components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol
(not as a preservative) and water for injection.

Both diphtheria and tetanus toxoids induce at least 2
units of antitoxin per mL in the guinea pig potency test. The potency of the
acellular pertussis vaccine components is determined by the antibody response
of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked
immunosorbent assay (ELISA).

Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.